MAUDE Adverse Event Report: BD CARIBE LTD. BD¿ QUINCKE SPINAL NEEDLE; ANESTHESIA CONDUCTION NEEDLE

Catalog Number	405180
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd¿ quincke spinal needle experienced mixed product type in packaging.The following information was provided by the initial reporter: the customer reported that they received a box of bd spinal needles #405180 lot # 2334994 without a different size tip than the 25g they ordered and listed on the packaging.Customer opened spinal needle 405180 and the needle had a different tip other than the 25gx3.5 as the packaging indicated.
Event or Problem Description
It was reported that the bd¿ quincke spinal needle experienced mixed product type in packaging.The following information was provided by the initial reporter: the customer reported that they received a box of bd spinal needles #405180 lot # 2334994 without a different size tip than the 25g they ordered and listed on the packaging.Customer opened spinal needle 405180 and the needle had a different tip other than the 25gx3.5 as the packaging indicated.
Additional Manufacturer Narrative
H6: investigation summary: one photo received by our quality team for investigation.Upon visual evaluation, two needles are seen; in one of the needles is observed the stylet is longer than the needle, therefore the stylet is protruding.A device history review was performed for reported lot 2334994, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Based on the teams investigation, possible root cause is associated with stylet out of alignment which orients the length and rotation of the cannula /stylet.

• Brand Name: BD¿ QUINCKE SPINAL NEEDLE
• Common Device Name: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16892307
• Report Number: 2618282-2023-00034
• Device Sequence Number: 6819278
• Product Code: BSP
• UDI-Device Identifier: 00382904051808
• UDI-Public: 00382904051808
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K210978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 405180
• Device Lot Number: 2334994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 06/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown